Author: Marine Dollat

Senior Regulatory Affairs Specialist



My client is an innovating and dynamic Medical Device company currently expanding their Regulatory Affairs Team.

Due to this growth my client is looking for a Senior Regulatory Affairs Specialist with a global experience to join them in Geneva area.

This position will report to the Regulatory Affairs Head.

YOUR RESPONSIBILITIES:

  • This position will be focused on the registration of Class III medical devices, in particular on US and Asian countries:

– Preparation of registration dossiers (ex : technical documentation, PMA and IDE)

– Manage the follow-up of the registration procedures and preparation of responses to Competent Authorities questions

– Assist the team in the Regulatory evaluation of US changes (Change control)

– Manage the maintenance of registration dossiers (modifications and renewals) for US

  • Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments
  • Prepare and support audits conducted by Notified Bodies and Competent Authorities
  • Be the regulatory affairs representative in the varied project teams
  • Key contact and support for distributeurs
  • Follow-up the regulatory monitoring for medical devices

YOUR PROFILE :

  • Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international area
  • Be familiar with US FDA regulations
  • Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)
  • Excellent knowledge of English language
  • Team player and enthusiastic individual, versatile and dynamic
  • Team-oriented personality
  • Ability to work in a dynamic environment
  • A first experience in project management would be a plus

For more details, please contact Marine Dollat at mdollat@axepta.com



Product Manager FR/GE

My client is an innovating, dynamic and growing international pharmaceutical and medical device currently looking for a Product Manager in Switzerland, Vaud Canton.

Despite its increasing growth, our client is a company with a human size and fast reactivity.

You will manage several products under the direction of the Marketing Manager

Your main missions:

•    Oversee the marketing plan for the products you are responsible for; including the objectives, strategy and action plan to increase sales and market share

•    Establish the planned marketing activities to promote your brands

  • Realize monthly market and competitive analysis and define appropriate actions
  • Ensure and manage the marketing budget for your products

•    Develop for each promotion cycle: marketing campaigns & promotional material in French and German

  • Train the sales representatives during the cycle meetings

•    Ensure the launch of new products

•    Work closely with the leader of the other department the Medical Director, the Quality & Regulatory Affairs Manager as well as the sales representatives

  • Presence in the field: visit centers and hospitals, participate in congresses and local symposia

Required profile:

  • University degree in Science with a post-graduate marketing qualification with at least three years’ experience in marketing, ideally in the pharmaceutical industry
  • Sales experience is an asset
  • You are able to set up a strategy, a marketing plan and work with all your partners both internally and externally to achieve your goals.
  • Strong project management skills
  • Fluent in French and German

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Analytical Scientist



My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their analytical team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Analytical Scientist with a strong expertise on Drug Substance and powder.

Responsibilities:


• Support to analytical development plan and stability program for primarily Drug Substance and possibly Drug Product in cooperation with external partner and internal experts, in line with business priorities, following a Quality by Design framework (ICH Q8, ICH Q11)
• Contribute to/or realize the conception, design, and interpretation of scientific and technical data to support projects decision making
• Apply broad and deep analytical knowledge and experience to the analytical development and characterization of drug substances and powder (e.g microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), quantification of API and impurities (HPLC, GC…)
• Design stability program in close cooperation with Internal Experts (e.g. CMC Development Expert, Head of Formulation and Process Development, Head of Chemical Development) and external partners
• Apply statistical analysis for interpretation of analytical and stability data, set the shelf life and storage conditions of drug substances
• Solve complex problems (e.g. deviations, OOS) through collaborations with others
•Create and enhance collaborative and trusting relationships with external partners
• Lead liaison with Operations to prepare, execute and support technical transfer to the late stage of development,
• Support Operations by providing scientific and technical expertise to ensure maintenance of in market products
• Manage to set a risk management table, update it as necessary and escalade in a timely manner any critical risk to the Supervisor
• Contribute to define and execute mitigation and contingency plan
• Plan efficiently activities and ensure strict monitoring of milestones and budget
• Laad and/or approve key documents such as: method development reports, validation protocols/reports, and justification of specifications, stability protocols/reports, shelf life and storage conditions statement and relevant sections of regulatory filings (DMF, IND, IMPD, NDA etc.)
• Write standard operating procedures and working instructions required by the activities
• Manage close oversight of GMP activities that are conducted externally to ensure at each stage of development an appropriate level of quality requirements and report in a timely manner any major or critical issue
• Contribute that external partners operate in compliance with Safety, Health and Environment of the company
• Participate to the preparation of audits and inspections, internally or at external partner’ site
• Maintain awareness of cutting-edge and specific technologies in the field of small molecule and ensure knowledge acquisition
• Ensure to implement regional regulatory requirements and guidelines that impact analytical sciences in close cooperation with CMC Development Expert and other functions
• Maintain current awareness of GMP and other regulations, guidance documents
• Contribute to publish/present in high quality journals/conferences in line with the function strategy

Your profile:

  • PhD with 5 years of working experience or MS with 15 years of working experience in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or closely related to the field
  • Strong track record of success with oral and topical developments
  • Experience working with external partners (e.g. CDMO, CRO, Academic)
  • In-depth scientific knowledge and experience in developing and validating analytical methods, covering different technics and methods (e.g. microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques
  • Solid understanding of characterization, technology transfer and troubleshooting when it comes to drug substances (Oral and Topical)
  • Fluency in English, both spoken and written, any other language an asset


For more details, please contact Marine Dollat at mdollat@axepta.com

Senior CRA

My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their global clinical team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Clinical Research Associate has responsibility for the delivery of the studies at allocated investigator sites and is an active participant in the local study teams. You will work in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You may oversee regular CRA activities including contract CRAs.

Summary of responsibilities:

  • Oversees clinical trial set up including site selection and set-up.                                               
  • Coordinates the overall interaction with clinical study sites and monitor CROs/site activities.      
  • Ensures quality and compliance with relevant regulatory standards according to procedural documents
  • Monitors sites or oversee monitoring activities by CROs to ensure quality and timeliness.                      
  • Ability to manage a phase 1 or small phase 2 clinical trial.                                                        
  • Review protocol for operational feasibility and organize feasibility studies to ensure appropriate country selection.                                                                   
  • Lead and coordinate the selection of investigators and ensure that the appropriate selection process has been utilized.                                                          
  • In collaboration with the CPM, make recommendations for the appropriate outsourcing of any required functions (e.g. monitoring, laboratory services etc.) and participate in the preparation of the related documentation.                                                                     
  • Assist the CPM with the preparation of bid grids, budgets and significant study milestones.
  • Establish country and/or site-specific recruitment targets with CRAs and CPM to meet timelines.
  • In collaboration with line function manager and CPM, participate in CRO and other third-party vendor selection; assist with the review of proposals and attend bid defenses as required.           
  • Coordinate and/or organize technical training at investigator meetings, CRO/CRA training meetings.
  • Ensure that all regulatory approvals have been obtained before initiation visits are conducted & that the appropriate documentation is available.                                                           
  • Ensure that appropriate documentation is available to the investigators in a timely manner.        
  • Ensure that clinical trial supplies are made available to investigators along with any other materials required by the protocol.                                                               
  • Manage, track and document CRO CRA activities by reviewing monitoring reports, tracking on-site visit frequency, organization of on­ site quality control visits as appropriate.  
  • Track recruitment and take appropriate steps to ensure recruitment targets are met
  • Track, measure and report any deviations versus the planned timetable

Work Experience:

  • Minimum of 5 years progressive relevant clinical experience in clinical operations including 3 years as Clinical Research Associate or equivalent with Pharma/Biotech and/or CRO.
  • Drug/device combination and biologics experience preferred.
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
  • Excellent knowledge of relevant local regulations.
  • Good understanding of the drug development process.
  • Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.

Education/Training:

University degree, preferably in life sciences or equivalent qualification

Senior Global Clinical Project Manager



My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton.
Due to this growth my client is looking for an International Senior Clinical Project Manager with strong experience in global clinical trial management.

Responsibilities:

• Responsible for leading and managing the multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.

• Responsible for the development of the Clinical Trial Outline (CTO) and Clinical Protocol.

• Ability to manage complex phase III clinical trial programs.

• Manages selection of study vendors for assigned studies.

• Manages vendor(s) throughout the life of assigned clinical trial(s).

• Selects investigational sites with input from Clinical Development and vendors.

• Reviews and refines Clinical Operations Plans including monitoring and other plans.

• Works with operations to oversees investigative sites’ adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel & CRAs.

• Provide input and contribute to the other study related documents.

• Plans and conducts investigator meetings, training sessions and KOL meetings as required.

• Review clinical regulatory documentation for the study submission including but not limited to CTA modules, IB, IMPD, EC, safety reports, labels.

• Works with CS, ME and project team as appropriate to develop the Clinical Study Report.

• Identifies and provides solutions to clinical trial issues or risk.

• Provide input together with the Clinical Project Team on responses to Health Authority questions and/or Ethic Committee/IRB.

• Mentors staff and serves as a resource for new employees.

• Provides or facilitate training to clinical study teams on protocol specific topics.

• Participates as appropriate in internal and external audits.

• Manages communication of study status and guidance to internal stakeholders.

• Manage subcontractors (CROs, experts …):

• Milestones and establish budget and timelines for the study conduct together with the study team. Establish a detailed planning of clinical project.

• Build, follow-up and close out study Budget following internal templates and instructions and according to the initially approved budget.

• Track all aspects of the Clinical Trial and make regular progress reports.

Your profile :

• University degree, preferably in a biologic/scientific discipline

• Minimum of 10 years experience in clinical operations including clinical project management or equivalent with Pharma/Biotech and/or CRO • Experience working on phase II and III at international level

• Ability to travel 30%

For more details, please contact Marine Dollat at mdollat@axepta.com



Senior Medical Device and Packaging Expert – auto-injector or pre-filled syringe

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a senior a medical device technology and packaging expert to provide to lead, design and oversee packaging and medical device technology strategy development (auto-injector or pre-filled Syringe).

Your responsibilities:

  • Lead and manage technical activities to address complex design, development, operational issues for the preparation and timely delivery of Primary and Secondary Packaging for combination products and topical delivery systems
  • Proposes the strategy for developing human factor engineering program for combination products
  • Contributes to develop early and late phase packaging and medical devices (e.g. delivery system for combination products)
  • Proactively contribute to implement regional regulatory requirements and guidelines that impact packaging and medical device activities in close cooperation with Pharmaceutical Development Expert
  • Interact closely with external partner to ensure selection of packaging and medical devices
  • Contributes to implement, with internal partners and external partners, scientific programs to ensure adequacy of the packaging and medical device solutions: leachable & extractible studies, shipment studies
  • Author, review and/or approve key documents such as development reports, validation reports, and relevant sections of regulatory filings (IND, IMPD, CTD)

Your profile:

  • PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field with at least 10+ years of relevant experience in pharmaceutical/medical device industry
  • You have excellent knowledge of Established track record of success with combination products development programs
  • You have demonstrated a successful experience with external partners
  • You have excellent knowledge in developing primary and secondary packaging, medical devices
  • You have excellent knowledge of cGMP, 21CFR820, ISO13485, ICH guidance’s, ISO standards and applicable guidelines
  • You have demonstrated a successful experience related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions
  • You speak and write English fluently

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Global Project Manager (biologics)



My client is an innovating, dynamic and growing international pharmaceutical company currently

expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Global Project Manager (biologics) to provide day-to-day project management leadership to global drug development project teams. He/she will maintain project plans and budgets, organize and lead project team meetings to meet goals

YOUR RESPONSIBILITIES:

  • Bring strong expertise with biological product development plans
  • Coordinates global, cross-functional, complex drug development project teams and provides advanced project management support, including action item tracking, organization and communication of materials.
  • Organizes interdepartmental activities to ensure completion of assigned projects within scope, on schedule and within budget constraints.
  • Identifies, monitors, and analyzes business project risks and prepares project planning contingency scenarios.
  • Ensures accurate tracking and reporting of project milestones and deliverables
  • Identifies and communicates resource constraints to senior management.
  • Prepares project updates for governance meetings and clearly communicates status in written documents and presentations.
  • Ensures documentation of, and access to, key project documents, presentations and data.
  • Assumes full responsibility for managing specific aspects of the project as designated by team leadership
  •  

Expected qualifications:

  • Bachelor or PhD degree (MBA)
  • At least ten years of relevant experience in experience in a Biopharma or Biotech environment with and seven years in a similar position in Project Management
  • Strong expertise in managing phase III and biological product.
  • Thorough understanding of the drug development processes
  • Hands-on expertise with project management tools (knowledge of Planiswere program will be a plus)
  • Ability to work on a Senior / Strategic level
  • Good understanding of financial and resource planning systems and processes and ability to coordinate project level budget/resource estimates and manage actuals vs. plan
  • Good communication
  • Fluent in English



Senior Global Regulatory Affairs Project Manager (device)

My client is an innovating and dynamic Medical Device company currently expanding their Regulatory Affairs Team.

Due to this growth my client is looking for a Senior Regulatory Affairs Specialist with a global experience to join them in Geneva area.

This position will report to the Regulatory Affairs Head.

YOUR RESPONSIBILITIES:

  • This position will be focused on the registration of Class III medical devices, in particular on US and Asian countries:

– Preparation of registration dossiers (ex : technical documentation, PMA and IDE)

– Manage the follow-up of the registration procedures and preparation of responses to Competent Authorities questions

– Assist the team in the Regulatory evaluation of US changes (Change control)

– Manage the maintenance of registration dossiers (modifications and renewals)

  • Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments
  • Prepare and support audits conducted by Notified Bodies and Competent Authorities
  • Be the regulatory affairs representative in the varied project teams
  • Key contact and support for distributeurs
  • Follow-up the regulatory monitoring for medical devices

YOUR PROFILE :

  • Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international area
  • Be familiar with US FDA regulations
  • Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)
  • Excellent knowledge of English language
  • Team player and enthusiastic individual, versatile and dynamic
  • Team-oriented personality
  • Ability to work in a dynamic environment
  • A first experience in project management would be a plus

For more details, please contact Marine Dollat at mdollat@axepta.com

In Vivo DMPK Lab Head (Germany)

My client, a growing mid-size pharmaceutical services company is currently growing their activities therefore looking for a In Vivo DMPK Lab Head to join one of their office near Munich area (with home-based flexibility offered)

Responsibilities:

  • The incumbent will act as study director for in vivo DMPK studies and provide DMPK expertise to client pre-clinical development plans and supervise the in-house laboratory animal studies
  • Together with management you will develop the organization into a high quality and leading European pre-clinical DMPK service site.
  • Leading a non-clinical in vivo DMPK lab staffed with scientists
  • In the role of Study Director / Principal Investigator take responsibility for the design, planning, execution and reporting of non-radioactive and radioactive preclinical ADME and PK studies for small and large molecule, if necessary according to GLP standards
  • Conduct interim DMPK analyses, interpret the data and attend client meetings to discuss study progression
  • Assume responsibility as deputy principal investigator according to animal welfare laws for all animal studies
  • Responsible for compliance with German law, GLP, GCP, guidelines and other applicable regulation (e.g., radio protection) pertaining to the R&D process, study conduct, and registration of drugs
  • Responsible (and accountable as per delegation) for and enforce adherence to safety measures in laboratories

Your profile :

  • University degree in the field of veterinary medicine, biology, pharmacy or equivalent natural sciences
  • In-depth knowledge of ADME principles and working knowledge of mouse and rat anatomy
  • At least 2 years professional experience in DMPK within a pharmaceutical environment
  • Experience in handling radioactive compounds
  • Experience with Phoenix WinNonlin
  • Experience in conduct of GLP compliant studies
  • Experience in authoring study reports and submission relevant dossiers
  • Qualification as principal investigator according to German animal welfare laws
  • Fluent in English (written and spoken), advanced knowledge in German